Additive Manufacturing (AM) Glossary

Layer-by-layer manufacturing process that creates parts directly from digital 3D data.

AM process that selectively deposits a liquid binder onto a powder bed to create a part, which is typically sintered after printing.

Direction in which a part is positioned during manufacturing, influencing quality, support structures, and mechanical properties.

Surface on which parts are manufactured during the AM process.

Maximum printable dimensions of an AM machine.

Process of demonstrating that specified requirements for products, processes, or organizations have been fulfilled.

Complete set of documents, models, parameters, and records required to manufacture and qualify a part.

Engineering approach that optimizes part design specifically for additive manufacturing processes.

Storage of qualified designs and manufacturing data instead of physical spare parts.

Production of qualified parts at multiple locations using standardized processes and controlled quality systems.

Structured method used to identify, evaluate, and mitigate potential process or product failures.

Verification that the first manufactured part meets all specified requirements before serial production begins.

Controlled thermal process used to achieve required material properties after manufacturing.

Real-time monitoring of manufacturing parameters to detect deviations during production.

Measurement and examination of parts to determine conformity with specified requirements.

International quality management system standard for medical device manufacturers.

International standard specifying requirements for quality management systems.

International standard defining terminology and fundamental principles for additive manufacturing.

International standard providing qualification principles for additive manufacturing production sites.

Demonstration that an AM machine consistently performs according to specified requirements.

Specific quantity of material produced under uniform conditions and identified by a unique batch number.

AM process in which material is deposited through a nozzle to build parts layer by layer.

Material characteristics such as strength, hardness, ductility, and fatigue resistance.

Inspection methods that evaluate parts without damaging or destroying them.

Demonstration that a manufactured part consistently meets all specified functional, quality, and regulatory requirements.

Manufacturing steps performed after printing, such as heat treatment, machining, surface finishing, or inspection.

AM process in which a laser selectively melts metal powder layer by layer to produce dense components.

AM process in which a laser selectively melts polymer powder layer by layer.

Controlled reuse of powder material according to defined quality criteria and documented procedures.

Demonstration that a manufacturing process consistently produces results meeting predefined requirements.

Confirmation through objective evidence that a manufacturing process reliably produces parts fulfilling their intended use.

Capability to manufacture parts repeatedly with controlled quality, performance, and regulatory compliance.

Demonstration that equipment, processes, materials, and personnel consistently meet defined requirements.

Planned and systematic activities that provide confidence that quality requirements will be fulfilled.

Operational techniques and inspections used to verify product conformity.

Structured framework for managing quality, documentation, traceability, and compliance.

Ability of a process to produce consistent results under the same operating conditions.

Ability to achieve consistent results across different machines, operators, or production sites.

Systematic evaluation of risks that may affect product quality, safety, or regulatory compliance.

Polymer powder bed fusion process where powder particles are fused using a laser without complete melting.

Continuous manufacturing of qualified parts under controlled and repeatable production conditions.

Documented instruction describing how a process shall be performed consistently.

Assessment of suppliers to ensure they meet technical, quality, and regulatory requirements.

Temporary geometry printed to stabilize overhangs and complex features during manufacturing.

Measure of the texture and finish of a manufactured surface.

Computational design method that minimizes material while maintaining structural performance.

Ability to track materials, equipment, processes, and records throughout the product lifecycle.

Confirmation that a process reliably produces parts fulfilling their intended use.

AM process in which liquid photopolymer resin is selectively cured by light to form solid parts.

Objective evidence that specified requirements have been fulfilled.